VenBom: A Phase 1 Study of Bomedemstat (IMG-7289), a Novel Inhibitor of Lysine-Specific Demethylase 1 (LSD1), in Combination With Venetoclax in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Terrence J Bradley, MD
Summary
This study aims to learn about the safety, tolerability, and different dose levels' safety profiles of Venetoclax and Bomedemstat (VenBom) combination therapy in participants with relapsed or refractory acute myeloid leukemia.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: A. Confirmed diagnosis of one of the following: 1\. Relapsed/refractory Acute Myeloid Leukemia (AML) following failure of at least one standard, front-line therapy. Patients must have an AML diagnosis per the World Health Organization (WHO) criteria, regardless of etiology, sub-type or treatment history. B. Adult male or female patients 18 years of age or older. C. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 (Appendix A: Performance Status Scales). D. Patients must satisfy the following laboratory criteria: 1. Total bilirubin ≤ 2 upper l…
Interventions
- DrugBomedemstat
Bomedemstat will be administered orally once daily via capsule.
- DrugVenetoclax
Venetoclax will be administered orally once daily via tablet.
Location
- University of MiamiMiami, Florida